OTC Medication Information: Pain Relief Aspirin Low Dose

PAIN RELIEF ASPIRIN LOW DOSE- aspirin tablet, delayed release
Rite Aid Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

  • facial swelling
  • shock
  • hives
  • asthma (wheezing)

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • take a blood thinning (anticoagulant) or steroid drug
  • have 3 or more alcoholic drinks every day while using this product
  • have had stomach ulcers or bleeding problems
  • take more or for a longer time than directed
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you have asthma
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

  • gout
  • diabetes
  • arthritis

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.

  • you experience any of the following signs of stomach bleeding:

    • have bloody or black stools
    • feel faint
    • vomit blood

    • have stomach pain that does not get better

  • ringing in the ears or a loss of hearing occurs

  • pain gets worse or lasts more than 10 days

  • fever gets worse or lasts more than 3 days

  • redness or swelling is present

  • new symptoms occur

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • do not take more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
  • children under 12 years: do not use unless directed by a doctor

Other information

  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • use by expiration date on package

Inactive ingredients

colloidal anhydrous silica, corn starch, FD&C red #40, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

1-800-426-9391

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Talk to your doctor or other
healthcare provider before using
this product for you heart.

NDC 11822-6451-4

Compare to the active ingredient in
St. Joseph® Low Dose Safety
Coated 81 mg Aspirin**

LOW DOSE PAIN RELIEF
ASPIRIN
ASPIRIN 81 mg

PAIN RELIEVER (NSAID)

Aspirin regimen

Safety coated

ACTUAL SIZE

500
ENTERIC
COATED TABLETS

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

**This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, owner of the registered trademark St. Joseph® Low Dose Safety
Coated 81 mg Aspirin.

50844 REV0122D64514

DISTRIBUTED BY: RITE AID
30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com

SATISFACTION GUARANTEE:
If you’re not satisfied, we’ll happilyrefund your money.

Rite Aid 44-645
(click image for full-size original)

Rite Aid 44-645

PAIN RELIEF ASPIRIN LOW DOSE aspirin tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-6451
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
FD&C RED NO. 40
FD&C YELLOW NO. 6
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
SHELLAC
DIMETHICONE
WATER
SODIUM BICARBONATE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIACETIN
TRIETHYL CITRATE
Product Characteristics
Color pink Score no score
Shape ROUND Size 6mm
Flavor Imprint Code L
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11822-6451-4 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:11822-6451-6 1 BOTTLE in 1 CARTON contains a BOTTLE
2 200 TABLET, DELAYED RELEASE in 1 BOTTLE This package is contained within the CARTON (11822-6451-6)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 07/25/2014
Labeler — Rite Aid Corporation (014578892)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 038154464 pack (11822-6451)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 manufacture (11822-6451)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (11822-6451)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 868734088 manufacture (11822-6451)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 967626305 pack (11822-6451)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 117025878 manufacture (11822-6451)

Revised: 08/2022 Rite Aid Corporation

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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